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Taiwan, Remote
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Job ID R0000013631
Category Clinical Trials
ABOUT THIS ROLE
Key Accountabilities:
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
- Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
- Provides regular site status information to team members, trial management, and updates trial management tools.
- Completes monitoring activity documents as required by SOPs or other contractual obligations.
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical
issues.
- Escalates site and trial related issues per SOPs until identified issues are resolved or closed.
Performs essential document site file reconciliation.
- Performs source document verification and query resolution.
- Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative
sites.
- Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
- Communicates with investigative sites.
- Updates applicable tracking systems.
- Ensures all required training is completed and documented.
- Serves as main observer/assessor of site activities.
- Facilitates audits and audit resolution.
- To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation.
- Mentors junior-level CRAs and serves as a resource for new employees.
- Serves as main observer of site activities, and may have some responsibilities for performance of site
May be assigned additional clinical operations tasks: - May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
- May be assigned clinical tasks where advanced negotiating skills are required.
Qualifications
- Includes CRA I qualifications in addition to the following:
- 1- 4 years of clinical monitoring experience required.
- Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
- An advanced degree (eg, MS, MBA, PharmD, etc) preferred.
- Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV])
preferred.
- Experience in coaching/mentoring other CRAs preferred
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